NCT01904292 is a Phase 1 clinical trial of Tocilizumab in Juvenile Idiopathic Arthritis, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT01904292?

NCT01904292 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT01904292?

Interventions in NCT01904292: Tocilizumab.

What condition does NCT01904292 study?

NCT01904292 studies Juvenile Idiopathic Arthritis.

Is NCT01904292 still recruiting?

NCT01904292 is currently completed. Last updated 20 November 2017.

Last reviewed 2017-11-20 · How we verify

NCT01904292

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis

Completed Phase 1 Last updated 20 November 2017

What this trial tests

Phase 1 trial testing Tocilizumab in Juvenile Idiopathic Arthritis in 52 participants. Completed in 13 June 2017.

Timeline

15 August 2013

Primary endpoint
13 June 2017

13 June 2017

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	15 August 2013
Primary completion	13 June 2017
Estimated completion	13 June 2017
Sites	42 locations across France, Italy, Russia, United Kingdom, Germany, Mexico, Argentina, Canada

Drugs / interventions tested

Tocilizumab (tocilizumab) — full drug profile →

Conditions studied

Juvenile Idiopathic Arthritis — all drugs for Juvenile Idiopathic Arthritis →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 1 to 17, any sex, with Juvenile Idiopathic Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (\<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (\>=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight \<30 kg.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Wound healing and cancer stem cells: inflammation as a driver of treatment resistance in breast cancer.
Arnold KM, Opdenaker LM, Flynn D, Sims-Mourtada J. · · 2015 · cited 84× · PMID 25674014 · DOI 10.4137/cgm.s11286
Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis.
Ruperto N, Brunner HI, Ramanan AV, Horneff G, et al · · 2021 · cited 29× · PMID 33506875 · DOI 10.1093/rheumatology/keab047
Long-term efficacy and safety of subcutaneous tocilizumab in clinical trials of polyarticular or systemic juvenile idiopathic arthritis.
Brunner HI, Ruperto N, Ramanan AV, Horneff G, et al · · 2024 · cited 14× · PMID 38552315 · DOI 10.1093/rheumatology/keae180
Proceedings of the 25th European Paediatric Rheumatology Congress (PReS 2018) : Lisbon, Portugal. 5-8 September 2018
· 2018
Proceedings of the 2018 Childhood Arthritis and Rheumatology Research Alliance (CARRA) Scientific Meeting : Denver, CO, USA. 12-15 April 2018
· 2018

Verify or expand the search:

Other trials of Tocilizumab

Trials testing the same drug.

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Other recruiting trials for Juvenile Idiopathic Arthritis

Currently open trials in the same condition.

NCT07243782 — Regulatory Post-Marketing Surveillance in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cose · recruiting
NCT05879419 — Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases · Phase 4 · active not recruiting
NCT06007456 — Clinical, Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis · recruiting
NCT03913962 — Health and Exercise Response in Children With Chronic and Auto-immune Pathologies · NA · recruiting
NCT06560606 — UCAN CAN-DU: Canada-Netherlands Personalized Medicine Network in Childhood Arthritis and Rheumatic Disease · recruiting

Other Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01904292 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 20 November 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01904292.

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